Semmelweis Lipid Center for High-risk Patients

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Semmelweis University

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

30 May 2023 → ongoing

Decision date (initial)

2024-10-22

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novartis Hungary Ltd

External identifiers

EU CT number

2024-519058-35-00

EudraCT number

2023-000166-33

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To show that a decrease in LDL-level is achievable with establishing a complex, intensive lipid management program.

Secondary objectives 1

1. To assess the efficacy of the program in reaching LDL-target and plaque regression.

Conditions and MedDRA coding

primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in atherosclerotic cardiovascular disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male or female ≥ 18 years of age at signing of informed consent
2. Subject agrees to the Maximum dose Statin therapy (Rosuvastatin min. 20 mg or Atorvastatin min. 40 mg) Fasting LDL-C local lab value at the Screening Visit ≥ 1.8 mmol/L proved atherosclerotic coronary disease (at least 1 of the below): 1)
3. proved atherosclerotic coronary disease (at least 1 of the below): 1) non-obstructive coronary plaques on CT scan in the last 6 months without revascularization, at least in 4 four regions (1-69% stenosis is 2 regions and 25-69% stenosis in 2 other regions); 2)proved acute coronary syndrome in one year with multi-vessel disease (at least 50% stenosis on another artery; post-PCI patient with at least 2 coronary XML File Identifier: ZRG11sdk8OXqmN4mxy3KFqZT0uQ=Page 11/22 arteries involved
4. Written informed consent must be obtained before any assessment is performed.

Exclusion criteria 7

1. Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception
2. Ongoing malignancy at the time of the first study visit
3. Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit.
4. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter must have AST and ALT ≤3x ULN
5. Use of other investigational drugs within 5 half-lives of the first study visit (Screening Visit), within 30 days (e.g., small molecules), or until the expected pharmacodynamic effect has returned to baseline (e.g., biologics), whichever is longer; or if required by local regulations. COVID-19 vaccines granted Emergency Use Authorization are not considered investigational drugs for the purpose of this study.
6. Heart failure (New York Heart Association (NYHA) class IV) at the Screening Visit.
7. current PCSK-9 inhibitor treatment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. absolute and percent change in LDL-level from first to last visit (mmol/L)
2. absolute and percent LDL-change from visit to visit

Secondary endpoints 5

1. change (from first to last visit) in percent of patients reaching LDL target (LDL<1.4 mmol/L)
2. change in coronary CT paramteres (total plaque volumen; „low-attenuation" plaque volumen; Agatston score; plaque composition; pericoronarial and pericardial fat tissue)
3. Ultrasound (femoral/carotid) endpoints: change in (from first to last visit): Total plaque area (mm2) Intima:media thickness plaque composition
4. change in BMI
5. Change in lifestyle, diet and health behaviour

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Semmelweis University

Sponsor organisation

Semmelweis University

Address

Varosmajor Utca 68, Kerulet Kerulet

City

Budapest XII

Postcode

1122

Country

Hungary

Scientific contact point

Organisation

Semmelweis University

Contact name

VSZÉK

Public contact point

Organisation

Semmelweis University

Contact name

VSZÉK

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications